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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5716_Библиотеки_им_академика_М_И_Перельмана
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[66] Malhotra, G.: My perspective for Pharmaceutical Manufacturing Technologies/Processes and
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306 Chapter 8 Road Map
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References 307
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
Index
180-day exclusivity 48
8-hydroxyquinoline 114
Abbott 14
abbreviated new drug application (ANDA) 24, 55
– Paragraph IV 48
AbbVie 24
active pharmaceutical ingredients 2, 52,
89, 277
– batch 54
advantage 187
Advil 8
affordable prices 62
Agfa 12
alcoholism 19
alizarinblue 18
allergy 7
alternate equipment 182
American Society for Testing and Materials 279
Anacin 8
analytical method 253
aniline 10
animal study
– data 45
– toxicity 45
Anthrax 12
antibiotics 6
antioxidant 91
antiparasitic 7
antipyrine
– fever-reducing 18
API cost contribution 280
API manufacturing 262
– outsourcing 281
API process development 292
API sell price 95, 127
Arrhenius behavior 189
aspirin 11, 20
asset utilization 50, 53, 55, 127, 184, 282
Astra AB 15
AstraZeneca 15
atorvastatin 8
auramine 18
autoimmune diseases 3
automation 13
Aventis 21
azeotrope 79
– toluene/water 195
azeotropic behavior 80, 162
azeotropic distillation 191
azeotropic properties 234
bacteria
– disease-causing 2
BASF 12
batch process 215
– cycle time 237
batch production infrastructure 281
batch reactor 163
Bayer 11–12
Beecham Group 4
benchmark 155
benchmarking 139
biocide 58
bioequivalence 48, 55, 108, 207
birth control pills 12
blind test 289
blockbuster drug 150
Boehringer Ingelheim 21
botanical plant 213
bottleneck 158
brand API manufacturer 155
brand API producer 126
brand molecule 125
brand pharma 206
brand (under patent) 177
Bristol-Myers Squibb 16
Burroughs Wellcome & Company 3
business model 185, 198, 282
– mortar/pestle 62
– pharma 62
business plan 77
business strategy 213
butylated hydroxy toluene 91
calcium carbonate 91
cancer 3
capital investment 50
carcinogenicity 84
CAS number 70
Cellcept 96
cellular phones 289
https://doi.org/10.1515/9783110702842-009
Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/
cGMP 23
cGMP practice 42
chemical 41
chemical engineer 278
– pharma process design engineer 51
chemical engineering 62, 70
– curriculum 50
chemical formula 70
chemical properties 70, 93, 125, 156
chemical supply house 93
chemical technology development 114
chemicals
– fine 17, 89
– organic fine 2
– specialty 2, 17, 89
Chemische Fabrik Griesheim-Elektron 12
Chemische Fabrik vorm. Weiler Ter Meer 12
chemist 278
chemistry, manufacturing and controls
(CMC) 49
chloramphenicol 9
chloroquin 35
chloroquine 25
chlorosulfonylation reaction 108
Ciba 17
Ciba-Geigy 17
cinchona tree bark 13
Cincinnati Chemical Works 17
ciprofloxacin 12
citric acid 7
Clairol
– hair care 16
– hair colors 16
Clarinex 7
Claritin 7
cleaning 76
cleaning practices 262
climate change 300
clinical research 44
clinical trial 107, 283
– approval 45
– controlled 46
– phase 3 207
clinical trials
– design 44
coal tar 1
cod liver oil 2
commercial operation 251
commercial scale 74
commercial supplier 76
commercial viability 298
commercialization 92, 128, 217
commercialization time 216
commonality 130
competitive pressure 156
conceptual phase 92
conservation 117
consolidation 128
contamination 215
continuous improvement 205, 216
contract manufacturing organization 240, 291
cooling fluid 188
cortisone 6, 10
cost 98, 145
cost analysis 59, 92, 136
cost reduction 96, 107
cost-effective process 106
costs 93
cough suppressant 11
creative destruction 290
creativity 121
creativity and imagination 293
crystallization 79
– continuous 195
curing value 277
curiosity and speed 277
current pricing 280
customer base 54
customer specification 184
cyanoguanidine 144
Cymbalta 14
DDT (dichlorodiphenyltrichloroethane) 17
de-bottlenecking 217
decanter 82
Delysid 19
demand 95, 278
density 78
– differences 81
density difference 162
design basis 278
design criteria 240
design parameter 258
desired state 287
development chemistry 128
development specialist 287
diabetes 22
diabetes, type 2 142
310 Index
diazonium salt formation 252
dicyandiamide 221
dicyanodiamide 226
dimethyl amine 222
dimethyl amine gas 143
dimethyl amine hydrochloride 221
dimethyl fumarate 58, 133, 155, 201, 215, 279
– stoichiometry 133
– synthesis 133
dimethylamine hydrochloride 144
disadvantage 117
disease 41
documentation 216, 240, 252
Dolophine 14
dosage 44
– micrograms to milligrams 41
– toxic 41
downtime 51, 76
drug 41
– biologic 41
– development 43
– discovery 42
– generic 42, 48
– identity 42
drug cost component breakdown 280
drug discovery 42
drug distribution 62
Drug Efficacy Amendment 23
drug price 280
drug selling price 95
economic process 127, 283
economics 49
economies of scale 55, 77, 117, 127, 196,
207, 282
ecotoxicology 94
E-factor 177, 184, 186, 205, 217, 277, 292
efficiency 160
efficient lowest cost 292
effluent treatment plant 106
effort 127
electrical tubular heater 298
electrically heated conveyor 189
electroplating industry 188
Elf Aquitaine 21
Eli Lilly 13
environmental factor 177
environmental impact 74
environmental standards 93
environmentally friendly 116–117
EPI suite 84
equipment 130, 158, 186, 214, 281, 293
– repurpose 196
equipment cleaning 263
equipment selection 240
erector set 186
erectors set 293
erythromycin 14
excess solvent 187
exotherm 83
expert advice 47
factory costs 62
fake definition 279
FDA
– review 42
fear of failure 54
feasibility 230, 278
feeder
– pump 190
– screw 190
fermentation technology 8
FIAT Final Report 940 114
filing process 93
financial benefit 116
financial justification 283
financial justification process 51
financial loss 53, 253
financial return 180
fine chemical companies 155
fine/specialty chemicals 214
finished dosage form 89
finished dose form (FDF) 41
flammability 69, 80
flash point 69
flexibility 160
Food and Drug Administration 279
– inspections 47
– PAT Team 178
– review 46
Food and Drug Administration (FDA)
– Advisory Committee 47
– filling process 48
formulation
– continuous 58
formulation method 51
formulation plant 145
formulations 56
Index 311
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Fortecortin 5
Fuchsine 10, 17
fumaric acid 201
fundamentals of science and engineering 117
gas 69, 74
Gates Foundation 107
Gaudi 127
Geigy 17
generic API 181
generic drug
– disease-curing value 54
generic drugs 19, 23
generic manufacturer 117, 180
generic (outside patent) 177
generic pharmaceuticals
– injectable 10
generic producer 207
Germanin 12
Gestafortin 5
glassware 130
Glaxo Laboratories 3
GlaxoSmithKline 2
global emission standards 206
global need 215
global population 62, 278
good laboratory practices (GLP) 43
gravity decanter 191
green chemistry 116, 121
green manufacturing processes 116
green process 116, 121
growth disorders 22
growth hormone 22
guaranteed fixed margin 280
Halcion 10
halothane 15
handling challenges 73
handling materials 74
Hatch-Waxman Act 24, 48, 183
hay fever 18
hazard 264
Health and Human Service 300
heat absorption
– gas 75
heat and mass balance sheet 237
heat balance 118, 237
heat capacity 80
heat exchanger 76, 187
– frame 298
– plate 298
– tubular 298
heat transfer 188
herculean task 120
heroin 11
high solvent use 291, 297
higher profitability 54
HIV drugs 107
Hoechst 12
Hoechst Marion Roussel 21
Horlicks 4
Hospira 10
household products 16
Humira 24
hydrocarbon processing 70
hydrochloric acid 143
hydrochlorothiazide 138, 198, 279
Ibuprofen 20
ICH Q11 295
ICH Q12 295
ICH Q7 295
ICHQ12 48
IG Farben 12, 24
imagination 121, 282
immiscible liquids 78
Imperial Chemical Company 15
impurity 220
impurity profile 108
in vitro 43
in vivo 43
incremental demand 54
Inderal 15
industrial grade 184
industry innovation 289
inert component 41
inert excipients 41, 89
information 272
innovation 277
– hindrance 281
innovation opportunity 278
innovative system 288
innovator companies 24
in-process testing 214, 282
insulin 13, 22
intermediate product hold tank 53
intermediates:
– reworked 50
312 Index
intermittent production 215
internal barrier 277
internal training 216
International Council for Harmonization 279
internet 70
inventiveness 128
inventory management 94, 196
investigational new drug (IND) 45
investment 282, 289
Jonas Salk 13
Kefauver Harris Amendment 23
knowledge base 216
labeling 42
laboratory chemistry stage 98
laboratory curiosity 283
laboratory development 76
laboratory equipment 278
laboratory experiment 131
laboratory process 127
laboratory scale 107
lack of confidence 54
large-scale 44
levothyroxine 154, 215, 279
limited space 188
limited volume 180
Lipitor 8
liquid 69, 73, 78
Listerine 8
living document 217
localized exotherm 189
logistics 164
long-term value 272
loop hole
– pay for delay 24
low volume product 282
lysergic acid diethylamide (LSD) 19
Macleans 4
malaria 25
maleic anhydride 201
manufacturing capacity 281
manufacturing chemistries 177
manufacturing process 42, 108, 151
– continuous 196
– improvement 234
– real status 120
manufacturing technology 298
– innovation 277
manufacturing
– batch 50
– continuous 49, 52, 145
– efficiency 128
– green 177
– modification to fit 50
– process selection 49
– process 131
– standards 89
– technologies 62
– technology 58
– technology innovation 54, 156
– upsets 128
market demand 62
marketing application 46
marketing authorization holder (MAH) 48
mass balance 70, 118–119, 237
material 74
material safety data sheets 218
material safety data sheets (MSDS) 70
material specifications 230
medicinal plants 41
medicines label 13
melt synthesis process 143
melting 189
melting point 73, 84, 132
Menova 5
mercaptopurine 3
Merck & Co 4
Merck KGaA 4
metering system 250
metformin 215, 221, 279
– batch process 222
metformin hydrochloride 142
metformin manufacturing 143
method of addition 216
methodology 132, 252
methyl anthranilate 90
metoprolol 147, 166, 192, 215, 279
metoprolol succinate 195
Michael Collins 177
Michelangelo 127
micronizing system 298
microorganism 41
microreactor 298
microreactors 161
modafinil 150, 155, 166, 203, 215
Index 313
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modular cooler 188
modular device 187
modular equipment 220
modular plant 159, 186, 263, 293
mole ratio 152
molecular weight 70
morphine 5
mortar and pestle philosophy 282, 293
Motrin 10
multiple plants 286
multiple sclerosis 58
mutual behavior 156
mutual behavior of chemicals 121, 130
mutual behavior of solvents 120
mutual solubility 132
mutually subsidized healthcare system 280
mycophenolate mofetil 96, 155
Nasivin 5
National Medal of Technology 16
National Psoriasis Foundation 133
net zero 178, 181
net-zero 300
Nevirapine 101
new drug application (NDA) 42, 46
Nexium 15, 202
nondestructive creation 167, 291
non-toxic materials 98
Nordic Insulin Laboratory 22
Novartis 17
Novo Nordisk 22
Nupercaine 18
Omeprazole 15, 145, 165, 202, 215, 218, 279
operating condition 216, 252
operating landscape 263
operating philosophies 184
operating rationale 216
operating strategy 213
opportunity cost 277
optimization 180
organic chemistry synthesis 1
organic emissions 293
organic synthesis 41
overcapacity 127
Paludrine 15
pancreas extracts 22
paper chemistry 98
paper synthesis route 93
paperwork 60
Parke-Davis 9
paroxetine hydrochloride 283
paroxetine mesylate 283
patent
– expiration 42, 55
– infringement 9
– life 59, 128
– modern law 9
penicillin 6
petroleum-based chemicals 1
Pfizer 7, 10
pharma industry 50
pharma manufacturing 288
pharmaceutical industry 205
pharmaceutical operating company 213
pharmaceuticals 53, 155, 177
pharmacy benefit manager (PBM) 49
pharma’s business model 301
phase 1 44
phase 3 44
Phenergan 8
phenobarbital 11, 23
phthalic anhydride 90
phthalimide 116
physical properties 69–70, 93, 125, 156, 195,
237, 257
– exploitation 81
Picasso 127
pill capsule
– gelatin capsules 13
– manufacturing 13
– sugar-coated 13
pilot plant 220, 301
pilot plant equipment 160
pitfall 158
plant efficiency 13
plug flow reactor 203
plug in device 187
pneumonia 11
polio vaccine 13
population 95
potential danger 264
potential synthesis routes 92
preclinical laboratory studies 43
preclinical research 43
prednisone 10
prescribing information. Siehe labeling
314 Index
Privine 18
process centricity 127, 185, 297
process chemistry 51, 217, 236, 295
process commercialization 119
process consideration 186
process control
– stoichiometry 52
process design 156, 216–217
process design rationale 216
process developer 91
process development 70, 93, 118, 230, 293
– chemical 89
– sequential 294
– time 230
– parallel 294
process documentation 216
process economics 91
process equipment 79–80, 130
– continuous cleaning 263
– design 242
– functionality 242
– modular 186–187
process facilitator 79, 161, 281
process heat 79
process improvement
– continuous 213
process inefficiency 280
process innovation 230
process optimization 107, 152, 157, 207
process productivity 79, 161
process scheme 252
process simplification 288
process stream 237
process technology 131
process value 297
process variables 213
process
– batch 50, 58, 77, 186
– best designed 281
– best fitted 281
– complexity 193
– continuous 50, 51–52, 76, 166, 215, 237, 251,
278, 281, 289, 293, 297, 299
– control technologies 51
– design 53
– eco-friendly 130
– economy 130
– feedback controls 53
– reactive equipment 51
– scale-up 131
– simplicity 292
– simplification 93
– stoichiometry 250, 253
– temperature 253
– time independence 50
– yield 74
processing equipment 185
– modular 216
processing steps 129
product accommodation 54
product changeover 263
product cost structure 51
product demand 49, 51
product ingredients 13
product quality 53, 214
product volume 132
production plant
– continuous 166
production run 207
production volume 185
productivity 153, 158
profit 58, 207
profitability 54, 158
profitability analysis:
– mortar/pestle method 54
profitability analysis
– mortar/pestle 56
profitability through simplicity 301
promising compound 43
prontosil 6, 12
protocol 44
proton pump inhibitors 15
Prozac 14
published literature 92
purification process 200
pyrmethyl alcohol 220
quality 158
quality by analysis 156, 161
quality by design 54, 161, 282
quality level 51
quality product 258
quality standards 89
quick assembly 160
quinine 13–14
raw material 69, 143, 184, 230
raw material economics 164
Index 315
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